An educational programme in neonatal intensive care units (SEPREVEN): a stepped-wedge, cluster-randomised controlled trial
Laurence Caeymaex
(1, 2)
,
Dominique Astruc
(3)
,
Valérie Biran
(4)
,
Leila Marcus
(5)
,
Florence Flamein
(6)
,
Stephane Le Bouedec
(7)
,
Bernard Guillois
(8, 9)
,
Radia Remichi
(10)
,
Faiza Harbi
(11)
,
Xavier Durrmeyer
(12, 13, 14, 1)
,
Florence Casagrande
(15)
,
Nolwenn Le Saché
(16)
,
Darina Todorova
(17)
,
Ali Bilal
(18)
,
Damien Olivier
(19)
,
Audrey Reynaud
(20)
,
Cécile Jacquin
(21)
,
Jean-Christophe Rozé
(22)
,
Richard Layese
(23, 24)
,
Claude Danan
(13, 12, 1)
,
Camille Jung
(21)
,
Fabrice Decobert
(21)
,
Etienne Audureau
(2)
1
CHI Créteil
2 UPEC UP12 - Université Paris-Est Créteil Val-de-Marne - Paris 12
3 CHU Strasbourg - Centre Hospitalier Universitaire [Strasbourg]
4 AP-HP Hôpital universitaire Robert-Debré [Paris]
5 CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
6 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
7 CHU d'Angers [Département Urgences]
8 LPCN - Laboratoire de psychologie de Caen Normandie
9 CHU Caen
10 Centre Hospitalier Intercommunal Poissy St Germain
11 Centre Hospitalier Delafontaine
12 BAR - Biomécanique & Appareil Respiratoire
13 U955 Inserm - UPEC - IMRB - "Biomechanics and Respiratory Apparatus" [Créteil]
14 CARMAS - Groupe de recherche clinique CARMAS (Cardiovascular and Respiratory Manifestations of Acute lung injury and Sepsis)
15 Neonatal Intensive Care Unit, CHU de Nice, Archet 2 Hospital, Nice, France
16 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
17 Centre Hospitalier René Dubos [Pontoise]
18 Service de Néonatologie [CHI Créteil]
19 DGD.C - Direction générale déléguée aux collections
20 Association SOS Prema
21 CHIC - Centre Hospitalier Intercommunal de Créteil
22 PhAN - Physiopathologie des Adaptations Nutritionnelles
23 Service de santé publique [Mondor]
24 CEpiA - Clinical Epidemiology and Ageing : Geriatrie Soins Primaires et Santé Publique
2 UPEC UP12 - Université Paris-Est Créteil Val-de-Marne - Paris 12
3 CHU Strasbourg - Centre Hospitalier Universitaire [Strasbourg]
4 AP-HP Hôpital universitaire Robert-Debré [Paris]
5 CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
6 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
7 CHU d'Angers [Département Urgences]
8 LPCN - Laboratoire de psychologie de Caen Normandie
9 CHU Caen
10 Centre Hospitalier Intercommunal Poissy St Germain
11 Centre Hospitalier Delafontaine
12 BAR - Biomécanique & Appareil Respiratoire
13 U955 Inserm - UPEC - IMRB - "Biomechanics and Respiratory Apparatus" [Créteil]
14 CARMAS - Groupe de recherche clinique CARMAS (Cardiovascular and Respiratory Manifestations of Acute lung injury and Sepsis)
15 Neonatal Intensive Care Unit, CHU de Nice, Archet 2 Hospital, Nice, France
16 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
17 Centre Hospitalier René Dubos [Pontoise]
18 Service de Néonatologie [CHI Créteil]
19 DGD.C - Direction générale déléguée aux collections
20 Association SOS Prema
21 CHIC - Centre Hospitalier Intercommunal de Créteil
22 PhAN - Physiopathologie des Adaptations Nutritionnelles
23 Service de santé publique [Mondor]
24 CEpiA - Clinical Epidemiology and Ageing : Geriatrie Soins Primaires et Santé Publique
Laurence Caeymaex
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Résumé
Background
Patients in neonatal intensive care units (NICUs) are at high risk of adverse events. The effects of medical and paramedical education programmes to reduce these have not yet been assessed.
Methods
In this multicentre, stepped-wedge, cluster-randomised controlled trial done in France, we randomly assigned 12 NICUs to three clusters of four units. Eligible neonates were inpatients in a participating unit for at least 2 days, with a postmenstrual age of 42 weeks or less on admission. Each cluster followed a 4-month multifaceted programme including education about root-cause analysis and care bundles. The primary outcome was the rate of adverse events per 1000 patient-days, measured with a retrospective trigger-tool based chart review masked to allocation of randomly selected files. Analyses used mixed-effects Poisson modelling that adjusted for time. This trial is registered with